RAP and BEAT Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)

NPO International TRI Network0 sites1,900 target enrollmentOctober 2014

ConditionsPercutaneous Coronary Intervention

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Percutaneous Coronary Intervention
Sponsor: NPO International TRI Network
Enrollment: 1900
Primary Endpoint: Radial artery occlusion
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

April 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NPO International TRI Network

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides written informed consent prior to the randomization, as approved by the appropriate IRB.
•Patient who is expected to diagnose by coronary artery angiography or followed by PCI.
•Patient must agree to undergo all protocol-required follow-up examinations.
•Patient who can accept radial access.

Exclusion Criteria

•Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
•Hemodialysis patient